Amplatzer Piccolo™ 9-PDS-04F-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067052926), received between Mar 23, 2026 and Sep 25, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 4F Amplatzer Piccolo Delivery System was chosen for a Patent Ductus Arteriosus (PDA) closure procedure on a 3week old, 1000grams premature infant. During procedure, the right femoral vein access was achieved in the usual manner and a 4F access sheath was placed. A non-Abbott wire and Piccolo Delivery System (PDS) combination was advanced up the inferior vena cava (IVC), across the tricuspid valve towards the right ventricular outflow tract (RVOT) and into the pulmonary artery(PA). The non-Abbott wire was advanced in an attempt to engage the PDA, but would not track down the descending aorta. The non-Abbott wire was then exchanged for an another non-Abbott glide wire which took an unusual course and appeared to be in the pericardial space. The baby was stable at this point. The glide-wire and PDS was then withdrawn back into the IVC at which point the baby become hypotensive and tachycardic. A transthoracic echocardiogram (TTE) assessment was done and revealed a rapidly accumulating 5mm circumferential pericardial effusion. The glide wire and PDS was then removed from the body and a pericardiocentesis was performed. A 8ccs of blood was removed

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 50897010 ↗
• MalfunctionMar 23, 2026Air/Gas in Device

  IT WAS REPORTED ON 11 FEBRUARY AN AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT USING A 4F AMPLATZER PICCOLO DELIVERY SYSTEM. ALL STEPS WERE PERFORMED PER INSTRUCTIONS FOR USE (IFU). WHILST INSERTING THE LOADER INTO THE TUOHY CONNECTED TO THE CATHETER WITHIN THE PATIENT, PRIOR TO INSERTING THE DELIVERY SYSTEM INTO THE FEMORAL VEIN, IT WAS NOTED THAT AIR CONTINUOUSLY OBSERVED IN THE HEMOSTATIC VALVE OF THE LOADER. A WET-TO-WET CONNECTION WAS CORRECTLY ESTABLISHED. BACKFLOW WAS USED TO REMOVE AIR BUBBLES. AN ATTEMPT WAS MADE TO DISCONNECT THE COMPONENTS OF THE DELIVERY SYSTEM AND RE-DO DEVICE PREPARATION. THE DEVICE WAS REPLACED WITH A NEW 16MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER. THE SAME DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663505 ↗